Gleolan for Ovarian Cancer Surgery (OVA-302)
This study is testing a drug called Gleolan to help surgeons find ovarian cancer tissue during surgery. Gleolan is given by mouth and helps tumor cells glow under a special blue light, making them easier to see. The study is for women aged 18 and older who have newly diagnosed, suspected, or recurrent epithelial ovarian cancer and are planning to have surgery to remove tumors. The main goal is to see how well Gleolan helps doctors find cancer that might otherwise be missed during surgery. The current status of this study is unclear.
- Study design
- This is a Phase 3 interventional study with a planned enrollment of 170 participants. It includes open-label training phases (Part A1 and A2) and a randomized pivotal portion (Part B).
- What's involved
- You would receive Gleolan, undergo blue light assessment, and have biopsies taken. You would also undergo standard ovarian cancer surgery. Individual participation is expected to last about two weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at surgery (Day 1), and individual study participation lasts about two weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
At a glance
Conditions
Where it's being run
11 sites across 9 statesStudy leadership
- Kristina Butler, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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What this trial measures
- To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.Surgery (Day 1)
Percentage of participants with at least one suspected ovarian cancer lesion (including lymph nodes) where Gleolan-induced FL is confirmed by central histopathology (Standard of Truth) to be tumor that was not detected during SoC debulking, among all participants who meet the eligibility criteria for the study and receive any amount of Gleolan.